The Business of Law – Marketing and Business for Enterprising Attorneys

Another medical device case type that we’ve been watching has to do with Calaxo Osteonconductive Interference Screws, also known simply as the Calaxo Screw. These devices are used to repair knee ligaments and promote bone growth most often after ACL repair or reconstruction. ACL injuries are common in many athletics including football, soccer, ice hockey and downhill skiing.

The Calaxo Screw was supposed to be an innovative product because it’s made of a bioabsorbably polymer, so that unlike conventional screws used to reattach ligaments, it could be reabsorbed by the body 12 months after surgery.

The problem is that the Calaxo Screw has been linked to graft failure and premature material degeneration. Symptoms include swelling, fluid build-up around the knee redness around the joint, loss of flexibility in the knee area, screw fragmentation, and localized joint pain. These side effects often require additional surgery to remove dead or infected tissue.

From 2006 to 2009, more than 300 adverse effects related to Calaxo Screws were reported to the FDA, and in August 2007, the manufacturer Smith & Nephew voluntarily recalled 68,000 units implanted worldwide. Some of the product was also recalled in October 2007 in the U.K.

There have been several suits filed alleging failure to warn patients about possible side effects. We’ll be monitoring the case, and may engage in a marketing effort targeting potential litigants who may have been given one of these screwed up screws as part of their surgery.